MJFF Grant Abstract:

Ethics of Sham Surgery Controls to Test Novel Parkinson's Disease Intervention
Rapid Response Innovation Awards 2007

Objective/Rationale:

When experimental treatments involve neurosurgery, researchers often use a placebo condition called sham surgery, which involves an invasive procedure (e.g., partial thickness burr holes). Some ethics review committees are concerned about the use of sham surgery in studies involving patients with a progressively debilitating disease such as PD because they are concerned such patients might volunteer with what ethicists call a therapeutic misconceptionthe subjects may believe they are being offered a "cutting edge treatment" when in fact they are being asked to serve as experimental subjects. It is important to clarify this important ethical issue since the use of sham surgery controls will likely increase with the development of new treatments for PD.

Project Description:In this project, we will interview actual participants of PD clinical trials that involve sham surgery controls. Using in depth interviews, we will assess the potential for the therapeutic misconception by describing why and how PD patients make their decisions regarding participation in sham surgery controlled studies. A semi-structured interview method has been developed to provide an in depth account of the subjects motivations, expectations, and understanding. The interview is designed to encourage participants to tell their stories, as a chronological narrative, so that a sense of how they came to make their decisions is revealed.

Relevance to Diagnosis/Treatment of Parkinsons Disease:

Since the use of sham surgery controls will likely increase with the development of new treatments for PD, policies will need to be developed regarding the use of sham surgery controls in neurosurgical trials. These policies should be informed by the perspectives of research participants. Our hope is to better understand the decisions patients make, to inform future policy decisions. In addition, this project will provide invaluable insights for optimizing informed consent practices for future sham surgery controlled trials.

Anticipated Outcome:

If our results indicate areas of concern, we will be able to inform policy makers of these issues and pinpoint potential solutions. If the results indicate a low incidence of misconceptions, it may allay current concerns over sham surgery, and help expedite the development of future neurosurgical trials.


Researchers

Karl Kieburtz
University of Rochester

Note: Dr. Kieburtz was also involved in the earlier survey of researchers about ethics of sham surgery. (discussed in our Neurotherapeutics article and sham surgery survey).



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there are no ethics in sham surgery...